{"id":51232,"date":"2022-11-24T15:02:28","date_gmt":"2022-11-24T14:02:28","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/eu-and-us-approach-to-the-development-of-drug-device-and-device-drug-combination-products-2-day-critical-interactions-training-course-february-20-21-2023-researchandmarkets-com\/"},"modified":"2022-11-24T15:02:28","modified_gmt":"2022-11-24T14:02:28","slug":"eu-and-us-approach-to-the-development-of-drug-device-and-device-drug-combination-products-2-day-critical-interactions-training-course-february-20-21-2023-researchandmarkets-com","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/eu-and-us-approach-to-the-development-of-drug-device-and-device-drug-combination-products-2-day-critical-interactions-training-course-february-20-21-2023-researchandmarkets-com\/","title":{"rendered":"EU and US Approach to the Development of Drug\/Device and Device\/Drug Combination Products: 2 Day Critical Interactions Training Course (February 20-21, 2023) &#8211; ResearchAndMarkets.com"},"content":{"rendered":"<div>\n<p>DUBLIN&#8211;(BUSINESS WIRE)&#8211;The <a target=\"_blank\" href=\"https:\/\/www.researchandmarkets.com\/reports\/5685013\/development-of-combination-products-critical?utm_source=BW&amp;utm_medium=PressRelease&amp;utm_code=mb2rr8&amp;utm_campaign=1780146+-+EU+and+US+Approach+to+the+Development+of+Drug%2FDevice+and+Device%2FDrug+Combination+Products%3A+2+Day+Critical+Interactions+Training+Course+(February+20-21%2C+2023)&amp;utm_exec=chdo54prd\" rel=\"nofollow noopener\" shape=\"rect\">&#8220;Development of Combination Products: Critical Interactions Training Course&#8221;<\/a> conference has been added to <strong>ResearchAndMarkets.com&#8217;s<\/strong> offering.\n<\/p>\n<p><a href=\"https:\/\/mms.businesswire.com\/media\/20221124005226\/en\/1646787\/4\/logo.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20221124005226\/en\/1646787\/21\/logo.jpg\"><\/a><\/p>\n<p>\nDrug\/device and device\/drug combination products are becoming increasingly important in the medical industry.\n<\/p>\n<p>\nThe development and manufacture of these products raises a number of complex issues and the quality and regulatory aspects are challenging.\n<\/p>\n<p>\nThis interactive seminar will clarify the EU and US approach to drug\/device and device\/drug combination products, address the requirements for the device technical file\/design file, explain the biological and synthetic drug regulations and look at the registration procedures for these products.\n<\/p>\n<p>\nThe programme will cover the regulatory strategy to adopt and the relevant aspects of GMP and quality processes, including the data expectations for the CTD. It will also review the key relationships between quality, regulatory, R&amp;D and production.\n<\/p>\n<p>\nDelegates will find this a comprehensive overview of the requirements for these products and will have an opportunity to discuss the complexities with an expert in this field.\n<\/p>\n<p>\n<strong>Benefits of attending:<\/strong>\n<\/p>\n<ul>\n<li>\nClarify the definitions for drug\/device and device\/drug combination products in the EU and USA\n<\/li>\n<li>\nConsider the requirements for the device technical file\/design file\n<\/li>\n<li>\nComply with the biological and synthetic drug regulations\n<\/li>\n<li>\nUnderstand the registration procedures for devices and medicines in the EU and USA\n<\/li>\n<li>\nDetermine the data required for the Common Technical Document (CTD)\n<\/li>\n<li>\nConsider the regulatory strategy depending on your product\n<\/li>\n<li>\nGain practical advice on how to apply the ISO standards\n<\/li>\n<\/ul>\n<p>\n<strong>Who Should Attend:<\/strong>\n<\/p>\n<ul>\n<li>\nAll development, regulatory and quality personnel involved in the development of combination products (drug\/device and device\/drug products)\n<\/li>\n<li>\nPharmacovigilance\/vigilance personnel\n<\/li>\n<li>\nDevice experts looking to expand their knowledge to medicines and vice-versa\n<\/li>\n<\/ul>\n<p>\n<strong>Key Topics Covered:<\/strong>\n<\/p>\n<p>\n<strong>Defining a drug\/device and device\/drug product<\/strong>\n<\/p>\n<ul>\n<li>\nEU approach\n<\/li>\n<li>\nUS approach\n<\/li>\n<\/ul>\n<p>\n<strong>Regulatory procedures for drug\/device and device\/drug products<\/strong>\n<\/p>\n<ul>\n<li>\nEU procedures\n<\/li>\n<li>\nUS and Office of Combination Products\n<\/li>\n<\/ul>\n<p>\n<strong>Understanding devices<\/strong>\n<\/p>\n<ul>\n<li>\nMedical Device Regulation &#8211; EU\n<\/li>\n<li>\nCE marking and Notified Body interactions\n<\/li>\n<li>\nCDRH definitions &#8211; US &#8211; 510(k) and PMA\n<\/li>\n<li>\nLabelling\n<\/li>\n<li>\nVigilance requirements\n<\/li>\n<\/ul>\n<p>\n<strong>Device technical file\/design file<\/strong>\n<\/p>\n<ul>\n<li>\nWhat is required\n<\/li>\n<li>\nStructure\n<\/li>\n<li>\nBench testing\n<\/li>\n<li>\nPotential clinical requirements\n<\/li>\n<\/ul>\n<p>\n<strong>Workshop: Technical file\/design file<\/strong>\n<\/p>\n<p>\n<strong>Understanding the biological and synthetic drug regulations<\/strong>\n<\/p>\n<ul>\n<li>\nEU\/US definition of medicinal product\n<\/li>\n<li>\nLabelling\n<\/li>\n<li>\nPharmacovigilance\n<\/li>\n<li>\nQuality requirements\n<\/li>\n<\/ul>\n<p>\n<strong>Registration procedures<\/strong>\n<\/p>\n<ul>\n<li>\nEU approach\n<\/li>\n<li>\nUS approach\n<\/li>\n<\/ul>\n<p>\n<strong>GMP and ISO standards<\/strong>\n<\/p>\n<ul>\n<li>\nPractical application\n<\/li>\n<li>\nInterpretation of the standards\n<\/li>\n<\/ul>\n<p>\n<strong>The CTD<\/strong>\n<\/p>\n<ul>\n<li>\nWhere to put data\n<\/li>\n<li>\nData expectations\n<\/li>\n<li>\nApplying QbD (quality by design)\n<\/li>\n<\/ul>\n<p>\n<strong>Workshop: CTD requirements &#8211; tracking critical documents<\/strong>\n<\/p>\n<p>\n<strong>Key considerations for the regulatory strategy<\/strong>\n<\/p>\n<ul>\n<li>\nDeciding which regulatory route to take\n<\/li>\n<li>\nDevice and product registrations\n<\/li>\n<li>\nCombination-only registrations\n<\/li>\n<li>\nDesired labelling\n<\/li>\n<\/ul>\n<p>\n<strong>Workshop: regulatory strategy<\/strong>\n<\/p>\n<p>\nFor more information about this conference visit <a target=\"_blank\" href=\"https:\/\/www.researchandmarkets.com\/reports\/5685013\/development-of-combination-products-critical?utm_source=BW&amp;utm_medium=PressRelease&amp;utm_code=mb2rr8&amp;utm_campaign=1780146+-+EU+and+US+Approach+to+the+Development+of+Drug%2FDevice+and+Device%2FDrug+Combination+Products%3A+2+Day+Critical+Interactions+Training+Course+(February+20-21%2C+2023)&amp;utm_exec=chdo54prd\" rel=\"nofollow noopener\" shape=\"rect\">https:\/\/www.researchandmarkets.com\/r\/hl65vu<\/a>\n<\/p>\n<p> <b>Contacts<\/b> <\/p>\n<p>\nResearchAndMarkets.com<br \/>\n<br \/>Laura Wood, Senior Press Manager<br \/>\n<br \/><a target=\"_blank\" href=\"&#109;a&#x69;l&#x74;o&#x3a;p&#x72;e&#x73;s&#x40;&#114;&#x65;&#115;&#x65;&#97;&#x72;&#99;&#x68;&#97;&#x6e;&#100;&#x6d;&#97;r&#x6b;e&#x74;s&#x2e;c&#x6f;m\" rel=\"nofollow noopener\" shape=\"rect\">&#112;&#x72;e&#115;&#x73;&#64;&#x72;e&#115;&#x65;a&#x72;&#x63;&#104;&#x61;n&#100;&#x6d;a&#x72;&#x6b;&#101;&#x74;s&#46;&#x63;&#111;&#x6d;<\/a><br \/>For E.S.T Office Hours Call 1-917-300-0470<br \/>\n<br \/>For U.S.\/ CAN Toll Free Call 1-800-526-8630<br \/>\n<br \/>For GMT Office Hours Call +353-1-416-8900\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>DUBLIN&#8211;(BUSINESS WIRE)&#8211;The &#8220;Development of Combination Products: Critical Interactions Training Course&#8221; conference has been added to ResearchAndMarkets.com&#8217;s offering. Drug\/device and device\/drug combination products are becoming increasingly important in the medical industry. The development and manufacture of these products raises a number of complex issues and the quality and regulatory aspects are challenging. This interactive seminar will &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/eu-and-us-approach-to-the-development-of-drug-device-and-device-drug-combination-products-2-day-critical-interactions-training-course-february-20-21-2023-researchandmarkets-com\/\">[Read more&#8230;]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-51232","6":"format-standard","7":"category-industry"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>EU and US Approach to the Development of Drug\/Device and Device\/Drug Combination Products: 2 Day Critical Interactions Training Course (February 20-21, 2023) - ResearchAndMarkets.com - Pharma Trend<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-trend.com\/en\/eu-and-us-approach-to-the-development-of-drug-device-and-device-drug-combination-products-2-day-critical-interactions-training-course-february-20-21-2023-researchandmarkets-com\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"EU and US Approach to the Development of Drug\/Device and Device\/Drug Combination Products: 2 Day Critical Interactions Training Course (February 20-21, 2023) - ResearchAndMarkets.com - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"DUBLIN&#8211;(BUSINESS WIRE)&#8211;The &#8220;Development of Combination Products: Critical Interactions Training Course&#8221; conference has been added to ResearchAndMarkets.com&#8217;s offering. 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